MAUDE Adverse Event Report: ETHICON INC. DERMABOND PRINEO 22CM SKIN CLOSURE; SURGICAL SEALANT

Catalog Number CLR222US

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Itching Sensation (1943); Rash (2033); Skin Discoloration (2074); Skin Irritation (2076)

Event Type  Injury  

Manufacturer Narrative

(b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.Additional information was requested and the following was obtained: please describe how the adhesive was applied on the tape - the incision was wiped down with water, and dried.Stratafix suture was used to close the subq.The surgeon typically uses 2 prineo with knee flexed.What prep was used prior to product application? unknown , but there has been no changes what date did the reaction occur on? 10-14 days was there any medical or surgical intervention performed (product removed; re-operation; re-closure; prescription steroids; antibiotics prescribed)? if so, please clarify ¿ some patients were referred to dermatology is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? unknown was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? unknown.

Event Description

It was reported that a male patient underwent a knee surgery on (b)(6) 2017 and topical skin adhesive was used.On (b)(6) 2017 the patient presented with a rash and itchiness.The rash started when the topical skin adhesive was taken off.The patient developed dermatitis.The patient was treated with steroid cream and then was put on keflex.On (b)(6) 2018 there was eschar in anterior surface around the incision.The rash was resolved.Additional information was requested.

• Brand Name: DERMABOND PRINEO 22CM SKIN CLOSURE
• Type of Device: SURGICAL SEALANT
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC. SAN LORENZO; road 183, km. 8.3; san lorenzo PR 00754
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7292535
• MDR Text Key: 100796646
• Report Number: 2210968-2018-71014
• Device Sequence Number: 1
• Product Code: OMD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: CLR222US
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/15/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR